D-0214-2025 Class II Ongoing
FDA drug recall D-0214-2025 was initiated by FDC Limited on January 23, 2025 and is designated Class II. Reason for recall: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. The recall status is ongoing. Affected quantity: 118104 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 12, 2025
- Initiation Date
- January 23, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 118104 bottles
Product Description
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
Reason for Recall
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Distribution Pattern
Distributed to one (1) Us Distributor in NJ
Code Information
Lot#: 083J033, Exp. Date 09/2025